Oral Mucositis Clinical Trial
Official title:
An Open-Label, Proof of Concept, Efficacy, Safety and Tolerability Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Prevention and Treatment of Oral Mucositis Induced by Radiation Therapy
Verified date | November 2021 |
Source | Santalis Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care. Santalis believes that the proposed study is a prudent and appropriate approach to investigate the potential of their product to prevent or improve oral mucositis symptoms commonly seen in subjects undergoing radiotherapy with or without chemotherapy.
Status | Completed |
Enrollment | 13 |
Est. completion date | May 20, 2017 |
Est. primary completion date | May 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subjects with head and neck cancer involving the oropharynx or oral cavity, who are expected to undergo high dose radiation therapy (i.e., = 60 Gy) that typically results in oral mucositis, with or without concurrent chemotherapy or biologic targeted therapy. 2. At least 18 years of age 3. Estimated survival of at least 6 months. 4. No prior radiation therapy to the head and neck area, and no chemotherapy within the last year except for induction chemotherapy delivered (or to be delivered) prior to the current course of radiation therapy 5. Female subjects of child-bearing potential must agree to use an adequate form of contraceptive (e.g., hormonal, barrier method or abstinence) prior to study entry and for the duration of the trial. 6. Are willing to refrain from using other treatments for oral mucositis until they consult with the study investigator(s). 7. Are able to give written informed consent in a manner approved by the Institutional Review Board and comply with the requirements of the study. Exclusion Criteria: 1. Have preexisting mucositis from other causes. 2. Are immunosuppressed or in chronic use of immunosuppressive drugs. 3. Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.). 4. Eastern Cooperative Oncology Group (ECOG) performance status > 3 5. Unwilling or unable to follow the protocol requirements. 6. Have any condition that in the opinion of the investigator would confound the efficacy, safety and tolerability assessments, such as oral thrush. 7. Have participated in any clinical trial in the previous 30 days. 8. Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study. |
Country | Name | City | State |
---|---|---|---|
United States | UTHSCSA Cancer Therapy and Research Center (CTRC) | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Santalis Pharmaceuticals, Inc. | The University of Texas Health Science Center at San Antonio |
United States,
Rosenthal DI, Trotti A. Strategies for managing radiation-induced mucositis in head and neck cancer. Semin Radiat Oncol. 2009 Jan;19(1):29-34. doi: 10.1016/j.semradonc.2008.09.006. Review. — View Citation
Singh CU NJ, inventors. : Derivatives of sandalwood oil and santalols for treating cold sores and herpes. . US patent application publication US2008/0058413 A1. 06 2008
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Will be Assessed Based on the Frequency and Severity of Adverse Events. | Adverse Events (AEs) will be assessed in accordance the Common Terminology Criteria for Adverse Events (CTCAE). The number of patients experiencing adverse events possibly, or probably related to the study product will be reported.
Possibly related: A clinical event, including laboratory test abnormality (if applicable), with a reasonable time sequence to administration of the drug, but which could also be explained by concurrent disease or other drugs or chemicals. Probably related: A clinical event, including laboratory test abnormality (if applicable), with a reasonable time sequence to administration of the drug, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal. |
[ Time Frame: Up to ten (10) weeks ] | |
Primary | Patients Achieving Less Than or Equal to "2" RTOG Score At Visit 9 | The Radiation Therapy Oncology Group (RTOG) is the measure of anatomical changes associated with oral mucositis. Patients scores will be compared to historical data of patient progression.
RTOG Scoring Criteria- Grade 0(none)- No change over baseline Grade 1(mild)- Irritation, may experience slight pain, not requiring analgesic Grade 2(moderate)- Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia Grade 3(severe) -Confluent, fibrinous mucositis, may include severe pain requiring narcotic Grade 4(life-threatening)-Ulceration, hemorrhage, or necrosis |
Up to ten (10) weeks | |
Secondary | Subject Self Reporting Burning or Irritation | Calculated by the number and percentage of subjects self reporting irritation of grade 1 (mild) or higher. | Up to ten (10) weeks | |
Secondary | NRPS (Numerical Rating Pain Scale) | Severity of pain in the oral cavity/oropharynx was measured using the numerical rating pain scale (NRPS) at each study visit. The NRPS is an 11-point scale from 0-10:
0 = No pain 10 = The most intense pain imaginable. |
Up to ten (10) weeks |
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